APPLICATION
ANDA071443
TYPE
ANDA
ORIGINAL APPROVAL
1988-11-10
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 10MG, PERPHENAZINE 4MG · TABLET · ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 50MG, PERPHENAZINE 4MG · TABLET · ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 2MG · TABLET · ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 10MG, PERPHENAZINE 2MG · TABLET · ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 4MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 44 · standardAP
2025-01-22Labeling · Supplement 43 · standardAP
2017-02-23Labeling · Supplement 32 · standardAP
2016-04-25Labeling · Supplement 30 · standardAP
2014-12-13Labeling · Supplement 29 · standardAP
2010-09-21Labeling · Supplement 25AP
2009-01-21Labeling · Supplement 24AP
2008-10-30Labeling · Supplement 23AP
2007-11-07Labeling · Supplement 21AP
2007-07-11Labeling · Supplement 20AP
2005-07-26Labeling · Supplement 15AP
2002-05-07Labeling · Supplement 12AP
1998-02-25Manufacturing (CMC) · Supplement 11AP
1998-02-05Manufacturing (CMC) · Supplement 10AP
1997-02-04Manufacturing (CMC) · Supplement 9AP
1995-06-28Labeling · Supplement 8AP
1993-10-22Manufacturing (CMC) · Supplement 5AP
1993-10-05Labeling · Supplement 7AP
1993-10-05Manufacturing (CMC) · Supplement 3AP
1993-09-01Labeling · Supplement 6AP
1990-01-31Manufacturing (CMC) · Supplement 2AP
1989-05-01Labeling · Supplement 1AP
1988-11-10OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.